NCT00476307已完成3 期
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Immune response 21 days post vaccination
研究概览
简要总结
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 18 years or above;
- •Non-childbearing or using adequate contraception;
- •Written informed consent obtained from the subject.
排除标准
- •Subjects must not:
- •Participate in a trial or using non-registered product;
- •Use immunosuppressants, blood products, or another influenza vaccine during study;
- •Have virologically confirmed influenza within 1 year;
- •Have allergic or acute disease;
- •Have unstabilized serious chronic disease;
- •Be a lactating female.
结局指标
主要结局
Immune response 21 days post vaccination
次要结局
- Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in AdultsInfluenzaNCT00706563GlaxoSmithKline120
已完成
3 期
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in AdultsInfluenzaNCT01144299GlaxoSmithKline114
已完成
3 期
A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in AdultsInfluenzaNCT00920374GlaxoSmithKline118
已完成
3 期
Ross River Virus (RRV) Vaccine StudyProphylaxis of Ross River Virus InfectionNCT01242670Resilience Government Services, Inc.1,968
已完成
3 期
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 StudyInfectious Disease by Haemophilus Influenzae Type bNCT01251133LG Life Sciences122